Mammalian colostrum derived nanopeptides for broadspectrum viral and recurrent infections with a method of isolation thereof

ABSTRACT

The present invention relates to nanopeptides isolated from mammalian colostrum with vaccine like antiviral and immunodulator activity via building body&#39;s own immune system and attachment inhibition on the cell surface receptors.

This is a National Phase Application filed under 35 U.S.C. 371 as anational stage of PCT/IN2009/000749, filed Dec. 29, 2009, an applicationclaiming the benefit from Indian Application No. 1353/MUM/2008, filedDec. 27, 2008, the content of each of which is hereby incorporated byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates to nanopeptides isolated from mammaliancolostrum with vaccine like antiviral and immunodulator activity viabuilding body's own immune system and attachment inhibition on the cellsurface receptors.

The Sequence Listing submitted in text format (.txt) on Sep. 7, 2011,named “seq.txt”, (created on Tuesday, Aug. 9, 2011, 1.61 KB), isincorporated herein by reference.

BACKGROUND OF THE INVENTION

Colostrum is the pre-milk substance produced from the mother's breastsof all mammals during the first 24 hrs of lactation typically first 3milks. Colostrum has been known as an immune booster since timeimmemorial. Colostrum triggers at least 50 processes in the newborn,including transferring all immune factors and the entire memory frommother's own immune system. Bovine colostrum is upto 40 times higherthan human colostrums in immune factors including nanoinformationalpeptides, Proline Rich Polypeptides, immunoglobulins, cytokines,interferon, lactoferrin and transfer factor. They are produced byT-lymphocytes and can transfer the ability to recognize a pathogen tonaïve cells. However, no one till date has been able to isolate activeingradients especially nano informational low molecular weightnanopeptides and formulate a product that has the same effect thatmother's first 3 milk, after the birth of child.

“Colostrum stimulates the lymphoid tissue providing benefits in aged orimmuno-deficient people” . . . Drs. Bocci, Bremen, Corradeschi, Luzziand Paulesu; Journal Biology. “Researchers reported that colostrumstimulates maturation of B Lymphocytes (type of white blood cell) andprimes them for production of antibodies, enhances growth anddifferentiation of white blood cells. Similar activity in cow and humancolostrum can also activate Macrophages” . . . Dr. M. Julius, McGillUniversity, Montreal: Science News.

“Bovine colostrum contains high levels of growth factors that promotenormal cell growth and DNA synthesis” . . . Drs. Oda, Shinnichi, et.al.;

Comparative Biochemical Physiology. “Drs. suggest that an important rolefor growth factors is in promoting wound healing. Accelerated healing ispossible for treatment with trauma and surgical wounds” . . . Drs.Bhora, et. al.; Journal. Surg. Res.

US 20070212367—This patent application discloses an immunologicallyactive PRP isolated from mammalian colostral fluids for treatment ofviral and non-viral diseases, a method and a system for processingmammalian colostral fluids and a pharmaceutical formulation.

Colostrum as such contains hundreds of small peptides which servenumerous purposes. Their segregation and isolation will facilitategathering of further information with regard to their individualfunction and help formulate specific and targeted therapies for numerousdiseases that are cured by colostrum. Studies have documented thepresence of number of bioactive peptides but no mention has been made ofthe use of these peptides fragments, their specific sequence orinformation regarding their isolation. The peptides are extremelysensitive to temperature, pH, stress and shear factors which posseseveral difficulties in their isolation and preserving their biologicalactivity. and method of collection of colostrum so as to deliver it tothe required patient by maintaining its full biological activity.

The present invention addresses these shortcomings by providing isolatednano-peptides from colostrum, their method of isolation and therapeuticuses of the isolated nano-peptide fragments.

SUMMARY OF THE INVENTION

One embodiment of the present invention provides for a formulationcomprising peptides isolated from mammalian colostrum having sequencesas recited in SEQ ID 1-8 hereinafter referred to as peptides of Radha108 series, wherein the peptides function to modulate cell immunity andprovide attachment inhibition for foreign antigen/viruses on cellsurface receptors along with crossing BBB (blood brain barrier) andtreating host of diseases in the brain

Colostrum is the pre-milk substance produced from the mother's breastsof all mammals during the first 24 hrs of lactation typically first 3milks. In one embodiment, colostrum used in the present invention is ofbovine origin. Bovine colostrum has 40 times higher immune factors thanhuman colostrum and has the ability to cure a number of viral, immuneand auto-immune disorders.

In another embodiment, there is provided a method of treatment of immunerelated disorders including autoimmune disorders the method comprisingof adiministering a patient suffering from such disorders atherapeutically effective amount of formulation comprising the peptidesof SEQ ID 108.

In yet another embodiment, there is provided a method of treatment ofAcquired Immune Deficiency Syndrome or AIDS the method comprisingadministering a patient suffering from AIDS, a therapeutically effectiveamount of formulation comprising the peptides of SEQ ID 1-8.

The formulation can be provided in a liquid, powder gel and any otherpharmaceutical delivery forms. It can be administered orally,intravenously or by means of dermal patch for adsorption through skin.

The present invention is illustrated with the help of accompanyingdrawings and detailed description and examples given below. The drawingsand example are for explanation and clarity purpose and do not in anyway limit the scope of the invention being defined by the appendedclaims and equivalents thereof. The foregoing aspects and advantages ofthe present invention will become more clear and appreciated by thedetailed description and examples.

BRIEF DESCRIPTION OF FIGURES

FIG. 1: Resolution of bovine colostrum sample used in the presentinvention through MS Spectra to give various protein fragments ofdifferent molecular weights.

FIG. 2: Percentage of cases with fatigue/malaise after the treatment.

FIG. 3: Percentage of cases with diarrhea after the treatment.

FIG. 4: percentage of cases with fever/cough after therapy.

FIG. 5: Number of patients at baseline and at end of treatment with CD4cell count range.

FIG. 6: Mean weight in kg during therapy.

FIG. 7: Number of patients with fatigue/malaise after therapy.

FIG. 8: Number of patients with fever/diarrhea with therapy.

FIG. 9: Number of patients having HIV associated skin rash and herpeszoster after therapy.

FIG. 10: Number of patients and CD4 cell count range.

A BRIEF DESCRIPTION OF THE INVENTION

The present invention relates to peptides isolated from colostrum, theirinnovative methods of collection, transport, storage, isolation andtherapeutic uses of the same.

One embodiment of the present invention relates to peptides isolatedfrom mammalian colostrum. The mammal can be bovine for example cow,goat, buffalo or any other suitable mammal. In one preferred embodimentof the present invention, the isolated peptides are obtained fromlactating cows and bufallos in particular. The peptides are short chainamino acid sequences which are fragile sensitive to temperature, pH andshear stress and difficult to isolate. These peptides are in asegregated form. They are not binded by any other molecule. The isolatedpeptides comprise of the group of SEQ ID (1-8) and will be hereinafterreferred to as Radha 108. Peptides of Radha 108 and do not coagulatebeing low in molecular weight. They are isolated from fat free wheyobtained from the colostrum.

The peptides of Radha 108 have a molecular weight in the range of 826 to2990 Da.

According to one embodiment of the present invention there is provided amethod for collection and processing colostrum and isolating small aminoacid sequences comprising of SEQ ID (1-8) the method comprising thesteps of, separating fat, cheese and colostrum whey, passing the wheythrough a series of filters to remove suspended solids and reducemicrobial load followed by ultra and nano filters to obtain a proteinfraction having a molecular weight of less than 10000 Da, specificallybelow 3500 Da wherein the filtration is done at a low pressure, minimalshear and temperature to preserve the Radha 108 nano peptides. Even thepumping means used to pump the liquid through the system consist ofpumps with low rpm. In one embodiment, the nano and ultra filters aredesigned to operate at a low shear and pressure of less than 5 Kg/cmsq.In another preferred embodiment, the filters are designed to operate inthe range of 0.5 kg/cmsq to 4 kg/cmsq. In yet another preferredembodiment, the filters are designed to operate at a pressure rangebetween 0.5 kg/cmsq and 2.0 kg/cmsq. Nano and ultra filtration ofproteins at such low pressures is virtually unheard off due to practicaldifficulties in obtaining effective amounts of protein within acceptabletime limits. The present invention thus overcomes the problem of priorart with regard to isolation and separation of small peptide molecules.

Colostrum is collected after delivery from mammal, and cooled to atemperature in the range of −20 deg C. within 3 hours to preserve thebiological activity of Radha 108 series nano peptides. Care is taken topreserve these sensitive peptides right from the collection stage byprovisions of special custom made non reactive plastic bags which helpin the non reactive aseptic collection of milk from the calf. Thehandlers and collector of the milk are to be provided specialinstruction for the collection in order to avoid drastic changed to thesensitive peptides so that they don't loose their activity. Thecolostrum is then gradually thawed at room temperature over night tobring the temperature to 4 to 5 deg C., and pumped to a cream separatorfor removal of fats at 4000 RPM at 45 deg C. It is then pasteurized byincreasing the temperature to 72 deg C. for 15 sec followed by coolingto 48 deg C. The colostrum is then received into cheese vat and treatedwith enzyme Rennet for 45-60 min to form curd and whey.

The whey is cooled and passed through a series of filters upto molecularexclusion nano and ultra-filtration at low pressure and temperature forseparation to peptides having a molecular weight of less than 10000 Da.After the process care is taken to adjust the pH and keep it constant inthe range of pH 4 to pH 6 in order to avoid degradation and loss ofbiological activity of the peptides of Radha 108. The protein fractioncontaining peptides less than 10000 Da.

In another embodiment of the present invention there is provided amethod of treating Acquired Immune Deficiency Syndrome or AIDS, themethod comprising administering a patient suffering from AIDS, atherapeutically effective amount of a formulation comprising peptides ofSEQ ID 1-8.

The peptides of the present invention block receptors GP120, 160, 180,41 and other cell receptor sites through which foreign antigen/virusenters the immune and other cell types. Topographically, these peptidesare similar to virus size and when they dock on these receptor sitesmimicking the virus/antigen, thereby limiting the entry of foreigninfectious agents though competitive attachment inhibition. The productalso has a vaccine like effect via providing memory to B Cells at stemcell level and preventing future outbreak of the disease.

In another embodiment of the present invention there is provided amethod of treating swine flu in mammals, the method comprisingadministering a patient suffering from swine flu, a therapeuticallyeffective amount of a formulation comprising peptides of Radha 108.

In another embodiment of the present invention there is provided amethod of treating immune disorders including autoimmune disorderscomprising administering a patient suffering from such disorders apharmaceutically effective dosage/amount of formulation comprisingpeptides of Radha 108.

The immuno-modulatory action of peptides of Radha 108 takes place bystimulating the maturation of immature thymocytes into either helper orsuppressor T cells, depending on the need of the body. Helper T cellspresent antigens (such as viral protein) to B lymphocytes, which produceantibodies to that antigen. Helper T cells also help produce memory Tcells, which retain the memory of an antigen in order to expedite theproduction of antibodies in the event the antigen is re-encountered inthe future creating vaccine like memory for the first time in history ofuse of colostrum. Suppressor T cells, on the other hand, deactivateother lymphocytes after an infection has been cleared to avoid damage tohealthy tissues. Peptides of the present invention also promote thegrowth and differentiation of B cells in the response to an infectionand the differentiation and maturation of macrophages and monocytes. Theactivity of Natural Killer cells from Thymus gland via Radha 108 seriesof peptide that crosses BBB (Blood Brain Barrier), cytotoxic cells ofthe innate immune system, was increased up to 5 times by the peptides(Radha 108) of the present invention.

The peptides of the present invention are also known to modulate thecytokine system as well. It stimulates the production of a wide range ofcytokines, including the pro-inflammatory cytokines tumor necrosisfactor-alpha (TNF-α) and interferon alfa and gamma (INF-γ) andanti-inflammatory cytokines interleukin (IL1, IL2, IL6, IL10, IL11,IL12) immuno-modulators.

The peptides of the present invention are small nanopeptides rangingbetween 800 to 3200 daltons and hence they are able to cross the bloodbrain barrier, and treat viral infections and neural disorders in brainvia signaling Pituitary gland located in the brain. It also acts on thesignaling pathways through Pituitary gland that sends signals to thymusin throat and stem cells in bone marrow, building body's own immunesystem naturally without the help of any other external medications.

According to another embodiment of the present invention there isprovided a pharmaceutical formulation comprising the peptides of thepresent invention as an active pharmaceutical ingredient (API) andpharmaceutically acceptable carriers. Optionally, the formulationfurther comprises Proline Rich Polypeptides or PRP's commonly found incolostrum as additional active ingredient. The formulation is used forthe treatment of wide range of diseases such as viral, bacterial,mycobacterium, fungal, parasitic, immune disorders including autoimmunedisorders etc.

According to another embodiment of the present invention there isprovided a method for treating a person suffering from immune relateddisorders the method comprising administering a the dose of formulationcomprising of peptides of the present invention in the range of 2 ml to5 ml in a spray form inside the mouth on buccal mucosa or on the anyother surface of body-skin or nasal cavity (4 times a day).

According to another embodiment of the present invention the formulationcan be applied topically or as a skin/trans-dermal patch or through thenasal or intravenous route.

The formulation of the present invention is known to cure around 108disease which include AIDS, allergies, Alzheimer, Benign ProstaticHyperplasia, Cancer, Hypertension, Lupus, Thrush, Autism, Perth'sdisease, Premenstrual syndrome and Endometriosis, Prion disease,Psoriasis, Sjogren's Syndrome, Spinal Muscular Atrophy,Thrombocytopenia, burns, infection insect bites, diaper rash, herpeticlesions, perther disease, Pharangitis, Porphyria, Raynaud's phenomenon,Sarcoidosis, Celiac disease, Chronic Pancytopenia, Crohn's disease,Diabetes type II, Fibromyalgia Rheumatic, Mononucleosis, MultipleSclerosis, Reuhmatoid Arthritis, Osteo Arthritis, Spinal MuscularAtrophy, Brown Recluse Spider Bite, Corneal Regeneration, diarrhea,Guillain Barre Syndrome, Hemolytic Anemia, Idiopathic Thrombocytopeniapurpura, Myasthenia Gravis, lupus, tuberculosis, HIV, Hepatitis A&C,Rebies in Dogs, Acute Viral Infections, Dengue fever, Human PapilomaVirus, Parvo, Pharangitis, Rabies, SARS, Shingles, Viral RespiratoryInfection, Plantar Warts, Colds and Flu, Lymphoma and Herpes Simplex I &II, wound healing, bone density building and skin elasticity, insulinlike growth factors, Anti aging etc.

Additional health benefits from Radha 108 series include Anabolic, AntiAging, Anti fungal, Anti-inflamatory, Anti-microbial, Assimilation,Atheletic performance, body building, bone density, cytokineenhancement, digestion, epithelial growth factors, friendly floraenhancement, insulin like growth factors, immunity booster,immunoglobulin, interferon, interleukins, intestinal permeability,lactoferrin, MSM, Muscle toning, skin elasticity, stamina, transforminggrowth factors, wound healing and weight loss for obese.

The invention will now be described with the help of example providedherein which is meant only for the purpose of illustration andunderstanding and does not in any way limit the scope of the presentinvention.

Example

Pregnant cattle were identified from various heard through the Amul'sKheda district of Anand in Gujarat India through computerized recordkeeping systems of Amul Dairy. Colostrum obtained from the cattle soonafter delivery was collected and stored in aseptic temperaturecontrolled collection vessels at a temperature of 4 deg C. to preservethe biological activity of the peptides. It was further freezed to −20deg C. till future processing. For separation of peptides of the presentinvention, colustrum was gradually thawed at room temperature over nightto bring the temperature to 4 to 5 deg C. It was then pumped to thecream separator for removal of fats at 4000 RPM at 45 deg C. This wasfollowed by pasteurization at a temperature of 72 deg C. for 15 secfollowed by cooling at 48 deg C. and receiving the pasteurized colostruminto cheese vat. Enzyme Rennet was added to the cheese vat and allowedto react for 60 min after which the curd formed was separated fromcolostrum whey. The whey was cooled to 4 to 10 deg C. It was then passedthrough a series of filters to remove suspended solids and microbialload all the way upto molecular exclusion nano ultra-filtration forseparation to peptides having molecular weight less than 10 kDa toobtain peptides of the present invention in a mixture along with Radha108 series and PRP's present in the colostrum. During processDifiltration is carried out by adding 10% purified water of total batchsize. Presence of the peptides of SEQ ID 1-8 was verified using HPLCtechniques.

Preservatives are added to tThe fraction obtained after ultra-filtrationand pH is adjusted between 4 to 6. The formulation was provided in aspray form in order to test its efficacy in human trial.

The patients who were administered formulation comprising peptides ofthe present invention were neither exposed before nor were on any otherdrugs especially, anti-retroviral and antibiotics therapies at the timeof administration of the drug. Thus, the formulation of the presentinvention can be effectively used as a standalone therapy.

WHO approved end points for assessing the therapeutic usage offormulation of the present invention were scientifically analyzedthrough the Indian Government sponsored and monitored study on 2 sets ofpatients at LTMMC and LTMG municipal tertiary care hospital in Sion,Mumbai with end point analysis for weight gain and clinical symptomscarried out the Sion Hospital and viralogical (viral load) andimmunological (absolute CD4 count analysis) being done at two separateinternationally recognized center (Institute of Immunoheamatology,Indian Council of Medical Research Institute in Mumbai and MetropolisCentral Laboratory in Mumbai India having approval from USA pathologicalassociation and accreditation from NABL, Department of Science andTechnology Government of India.

The statistical analysis of both these sets of studies were undertakenat the premier medical research institute in India; All India Instituteof Medical Sciences New Delhi.

A. Initially, 50 participants were evaluated in the clinic once a weekthrough the first 4 weeks of therapy, and then every 2 weeks for theremaining 8 weeks of the study. They were evaluated about clinical andphysical symptoms via symptom assessment form, physical examination,side effect of treatment and compliance to the drug on follow up visits.Blood tests to measure CD4 cell count, HIV viral load, heamoglobin,white blood cell count, liver function test and renal function test weredone at baseline and at end of 12 weeks study.

CD4 and CD8 cell count were analyzed via Flow Cytometry and Viral Loadvia Polymerase Chain Reaction at the beginning and at the end of 12weeks.

Primary efficacy end points of study was the effect of this therapy onthe markers of HIV disease including clinical symptoms and physicalfindings, weight gain/loss along with the general well being of thepatients and HIV viral load and CD4 cell count, which showedconsistently positive results in both the trials conducted since 2005Onwards.

Weight Gain: Consistent weight gain was observed in all patients onfollow-up visits, which was one of the primary end point (Table 1). Theaverage weight gain after 12 weeks of treatment was 4.73 kg per patient,which is statistically highly significant (p<0.001).

TABLE 1 changes in meanweight after treatment Duration in weeks Meanweight (N = 50) basal 50.48 ± 10.97 2 50.77 ± 11.26 3 51.38 ± 10.94 452.33 ± 10.73 6 53.89 ± 11.17 8 54.59 ± 10.89 10  55.44 ± 11.07 12 55.21 ± 9.42 

Clinical parameters: All the clinical symptoms disappeared during the 12weeks of treatment. These reductions are statistically significant(p<0.05).

Fatigue/malaise: 88% of the total study cases had symptoms of fatigue atbasal. After treatment at the end of 2^(nd) week proportion of symptomsof fatigue had a significant fall from basal. After 6^(th) week onwardsonly one or two patients had fatigue (FIG. 2).

Diarrhoea: 18% of the total study cases had diarrhea at basal and aftertreatment from 5^(th) week onwards all the patients had relief fromdiarrhea (FIG. 3).

Fever: Fever was reported by 24% of total study cases at basal and from7^(th) week onwards not a single patient had fever with significant fallstarted 4^(th) week onwards.

Cough: 28% of the total study cases had a symptom of cough at basalwhich had significant fall from 3^(rd) week onwards and all improved10^(th) week onward (FIG. 4).

Skin rash and Herpes Zoster: 14% and 12% of total study cases had skinrash and herpes zoster at basal respectively and from 4^(th) weekonwards not a single patient had suffered from skin rash.

Similarly, nausea, vomiting and disturbed sleep were improvedsignificantly during therapy with formulation of the present invention.

Absolute CD4 cell count and HIV viral load: CD4 cell count was availablefor 48 patients with pre and post treatment values. There was increasein CD4 count on the average by 51 (median CD4 cell counts from 312 to363). This is of borderline statistical significance (p=0.06). 30 out of48 (62.5%) patients showed rise in CD4 count and 18 patients (37.5%)showed decrease in CD4 cell count. CD4 cell count range with number ofpatients at baseline and at the end of study is shown in FIG. 5.

The mean HIV log viral load has statistically significantly dropped from4.63 to 4.18 after 12 weeks of treatment (p=0.03). Similar trend is alsoseen in the pre treatment and post treatment median viral loads (from92458 vs. 25332, p_(<)0.001).

B. Another study was carried out with 51 HIV positive patients by theadministration of the formulation comprising peptides of the presentinvention for twelve weeks. The results obtained are as follows:

Weight gain: Weight monitored on every visit showed significant gain inall 51 HIV patients with mean weight gain of 4.68±1.9 kg after 12 weeks(FIG. 6)

Clinical parameters: All the clinical symptoms had disappeared duringthe 12 weeks of treatment (most of them had disappeared within 3 weeks).These reductions are statistically significant (p<0.05).

Fatigue/malaise: 100% of the total study cases had symptoms of fatigueat basal. After treatment at the end of 2^(nd) week proportion ofsymptoms of fatigue had a significant fall from basal. After 6^(th) weekonwards all patients had relief from fatigue (FIG. 7).

Fever and diarrhea: 100% of the total study cases had fever and diarrheaat basal and after treatment from 3^(rd) week onwards. All the patientshad relief from diarrhea and fever (FIG. 8).

Skin rash and Herpes Zoster: All the patients had HIV associated skinrash and herpes zoster at basal and became asymptomatic after 3^(rd)week onwards with treatment. (FIG. 9)

Similar improvement seen in nausea, vomiting, cough and disturbed sleepand all patients became asymptomatic from 3^(rd) week onwards.

Absolute CD4 cell count: CD4 cell count was available for all 51patients with pre and post treatment values. There was increase in CD4count on the average by 27 (median CD4 cell counts from 276 to 305).This value is statistically significant (p=0.042). CD4 cell count rangewith number of patients at baseline and at the end of study is shown inFIG. 10.

HIV viral load: After RADHA108 series 12-week treatment, at the end ofstudy mean viral load showed a significant fall (p<0.001) from thebaseline.

Side effects: All patients tolerated the formulation of presentinvention well with no side effects.

C. The output of the statistical analyses of the study carried out on 50HIV positive patients is as follows:

Sr. No. Parameter Before After 12 Weeks P-value I. Physical (N = 50) 1.Weight 50.48 (10.97) 55.21 (9.42) <0.001 II. Clinical Symptoms (N =50) 1. Fatigue 44 (88%) 0 (0%) <0.001 2. Diarrhea 9 (18.0%) 0 (0%) 0.0043. Nausea 8 (16%) 0 (0%) 0.008 4. Vomiting 7 (14%) 0 (0%) 0.02 5. Fever12 (24%) 0 (0%) <0.001 6. Cough 14 (28%) 0 (0%) <0.001 7. TB 6 (12%) 0(0%) 0.03 8. Disturbed Sleep 13 (26%) 0 (0%) <0.001 9. Rash On Skin 7(14%) 0 (0%) 0.02 10. Herpes Zoster 6 (12%) 0 (0%) 0.03 III.Virological 1. Log of HIV-I, 5.11 (0.090) 4.103 (1.32) <0.001 RNA n = 34206057 25280 <0.001 Median HIV-I 62884 1665 RNA 508038 87511 25^(th)Percentile 75^(th) Percentile IV. Immunological 1. CD4 count 312.5 363.50.06 (N = 48) 275.5 294.2 Median 430 435 25^(th) Percentile 75^(th)Percentile

These results show that formulation containing nano-peptide of thepresent invention are effective and safe drug in increasing weight andgeneral well being of patients, with decrease in viral load and increasein CD4 cell count. Thus, peptides of the present invention as activepharmaceutical ingredients hold good promise for the treatment of HIVpatients across all age groups.

The Radha 108 series peptides of the present invention are active in thetreatment of various diseases and conditions as explicated above.

The invention claimed is:
 1. A formulation comprising between 0.1% to 1%by volume of peptides isolated from mammalian colostrum having sequencesas recited in SEQ ID 1-8 wherein the peptides function to modulate cellimmunity and provide attachment inhibition for foreign antigen/viruseson cell surface receptors.
 2. The formulation as claimed in claim 1wherein SEQ ID 1 represents a peptide sequence having a sequence asELVPGVPRGTQL.
 3. The formulation as claimed in claim 1 wherein SEQ ID 2represents a peptide sequence having a sequence as VAIIQHMIKKLR.
 4. Theformulation as claimed in claim 1 wherein SEQ ID 3 represents a peptidesequence having a sequence as LPQEVLNENLLRF.
 5. The formulation asclaimed in claim 1 wherein SEQ ID 4 represents a peptide sequence havinga sequence as RLNARMAELR.
 6. The formulation as claimed in claim 1wherein SEQ ID 5 represents a peptide sequence having a sequence asSSLQVLNMSHN.
 7. The formulation as claimed in claim 1 wherein SEQ ID 6represents a peptide sequence having a sequence as EYQELMNVK.
 8. Theformulation as claimed in claim 1 wherein SEQ ID 7 represents a peptidesequence having a sequence as VDTLNDEINFLR.
 9. The formulation asclaimed in claim 1 wherein SEQ ID 8 represents a peptide sequence havinga sequence as DGIVNENLAER.
 10. The formulation as claimed in claim 1wherein the mammalian colostrum is bovine colostrum.
 11. The formulationas claimed in claim 1 wherein the formulation helps in increasing thelevel of CD4 cells for use in treatment of immune related disease. 12.The formulation as claimed in claim 1 wherein the formulation helps inweight gain of the patient.
 13. The formulation as claimed in claim 1wherein the formulation helps in reducing clinical symptoms of diarrhea,nausea, vomiting, cough and skin rashes.
 14. The formulation as claimedin claim 1 wherein the formulation helps in reduction of viral load inthe body.
 15. The formulation as claimed in claim 1 further comprisingpeptides isolated from mammalian colostrum and having a molecular weightless than 10000 Da.
 16. The formulation as claimed in claim 1 furthercomprising pharmaceutically acceptable carriers.
 17. The formulation asclaimed in claim 1 wherein it is applied topically, as a skin dermalpatch, as a skin spray or as a nasal or intravenous solution.
 18. Amethod for the treatment of Acquired Immune Deficiency Syndrome (AIDS),the method comprising administering to a patient suffering from suchdisorder a therapeutically effective amount of the formulationcomprising peptides of SEQ ID 1-8 as claimed in claim
 1. 19. The methodas claimed in claim 18 wherein the peptides are synthetic peptides. 20.The method as claimed in claim 18 wherein the formulation comprises 0.3%of protein.
 21. The method as claimed in claimed in 18 wherein theformulation is administered in an amount of 2 ml to 5 ml four times aday.
 22. A process for isolating peptides from mammalian colostrumhaving SEQ ID 1-8 as defined in claim 1, the process comprising thesteps of: a. separating fat, Cheese and colostrum whey; b. passing thewhey through a series of filters to remove suspended solids and reducethe microbial load; c. passing the whey obtained from step (b) throughultrfiltration to obtain amino acid sequences having molecular weight ofless than 10000 kDa; wherein ultrafiltration is done at low pressure andtemperature to preserve the amino acid sequences.
 23. The process asclaimed in claim 22 wherein the ultrafiltration is carried out at apressure less than 5 kg/cmsq.
 24. The process as claimed in claim 22wherein the ultrafiltration is carried out at a pressures in the rangeof 0.5 kg/cmsq to 4 kg/cmsq.
 25. The process as claimed in claim 22wherein the ultrafiltration is carried out at a pressure of 2.0 kg/cmsq.